International Cancer of the Pancreas Screening (CAPS) Consortium summit on the management of patients with increased risk for familial pancreatic cancer.
Marcia Irene Canto, Femme Harinck, Ralph H Hruban...
https://pubmed.ncbi.nlm.nih.gov/23135763Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06330441
Pancreatic Cancer Screening in a Population at High Risk
Led by Masaryk Memorial Cancer Institute · Updated on 2026-04-21
700
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
Sponsors
M
Masaryk Memorial Cancer Institute
Lead Sponsor
M
Masaryk University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pancreatic ductal adenocarcinoma (PDAC) is a cancer with one of the worst prognoses, mainly due to its late diagnosis and rapid progression. In the Czech Republic, the incidence of this cancer has been increasing, with a very low overall five-year survival rate between 7-9%. Early detection is challenging because symptoms are often absent or non-specific, and current screening methods are limited. This trial focuses on screening individuals at high risk for pancreatic cancer, aiming to improve early diagnosis and potentially increase the chances of curative treatment. The study evaluates different screening methods including endoscopic ultrasonography, magnetic resonance imaging, and laboratory tests such as blood markers related to pancreatic health. Participants are grouped based on their risk factors, such as chronic pancreatitis, specific genetic mutations linked to hereditary syndromes, or a family history of pancreatic cancer. Screening frequency varies by group and is planned for up to 60 months, with annual monitoring through the specified procedures. Participants in the study will undergo regular imaging and laboratory examinations to detect pancreatic cancer early. Researchers will track the number of new pancreatic cancer cases diagnosed during the study and compare the effectiveness and cost-efficiency of the screening methods. They will also evaluate the presence of certain genetic mutations over time. The study includes ongoing monitoring to ensure participants can undergo the necessary imaging and potential surgery if needed. The total participation time can extend up to five years.
CONDITIONS
Brief Title
Pancreatic Cancer Screening in a Population at High Risk
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Willing to participate in the study
- Age 18 years or older
- For arm A: chronic pancreatic disease related to cystic fibrosis or chronic pancreatitis and age 50 years or older
- For arm B1: confirmed Peutz-Jeghers syndrome (STK11 mutation) with age over 35 years or 10 years before earliest family pancreatic cancer diagnosis; familial melanoma syndrome (CDKN2A mutation) with age over 40 years or 10 years before earliest family diagnosis; or hereditary pancreatitis (PRSS1 mutation) with age over 40 years or 20 years after first attack
- For arm B2: confirmed hereditary syndrome (Lynch, HBOC, familial adenomatous polyposis, Li-Fraumeni syndrome) with at least one first- or second-degree relative diagnosed with pancreatic ductal adenocarcinoma, age over 50 years or 10 years prior to youngest relative's diagnosis, whichever is earlier
- For arm C: positive family history of pancreatic ductal adenocarcinoma without hereditary syndrome, age 50 years or older or 10 years before youngest relative diagnosis
You will not qualify if you...
- Unable to undergo radical curative surgery for a pancreatic tumor
- Unable to undergo scheduled imaging examinations
- Presence of incurable malignant cancer
AI-Screening
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1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Surveillance
Duration - Up to 60 months
Participants undergo regular pancreatic cancer screening using endoscopic ultrasonography, magnetic resonance imaging, and laboratory examinations according to their assigned risk group.
Annual visits for up to 5 years
Trial Site Locations
Total: 1 location
1
Masaryk Memorial Cancer Institute
Brno, Czechia, 65653
Actively Recruiting
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Research Team
M
Martina Lojova, Ph.D.
D
Dita Kozakova, Ing.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
4
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Published Research Related To This Trial
ACG clinical guideline: Genetic testing and management of hereditary gastrointestinal cancer syndromes.
Sapna Syngal, Randall E Brand, James M Church...
https://pubmed.ncbi.nlm.nih.gov/25645574Evaluating Susceptibility to Pancreatic Cancer: ASCO Provisional Clinical Opinion.
Elena M Stoffel, Shannon E McKernin, Randall Brand...
https://pubmed.ncbi.nlm.nih.gov/30457921Deleterious Germline Mutations Are a Risk Factor for Neoplastic Progression Among High-Risk Individuals Undergoing Pancreatic Surveillance.
Toshiya Abe, Amanda L Blackford, Koji Tamura...
https://pubmed.ncbi.nlm.nih.gov/30883245Refinement of screening for familial pancreatic cancer.
D K Bartsch, E P Slater, A Carrato...
https://pubmed.ncbi.nlm.nih.gov/27222532A multicentre comparative prospective blinded analysis of EUS and MRI for screening of pancreatic cancer in high-risk individuals.
F Harinck, I C A W Konings, I Kluijt...
https://pubmed.ncbi.nlm.nih.gov/25986944Cost-effectiveness of Pancreatic Cancer Surveillance in High-Risk Individuals: An Economic Analysis.
Juan E Corral, Ananya Das, Marco J Bruno...
https://pubmed.ncbi.nlm.nih.gov/30946242Benefit of Surveillance for Pancreatic Cancer in High-Risk Individuals: Outcome of Long-Term Prospective Follow-Up Studies From Three European Expert Centers.
Hans Vasen, Isaura Ibrahim, Carmen Guillen Ponce...
https://pubmed.ncbi.nlm.nih.gov/27114589Risk of Neoplastic Progression in Individuals at High Risk for Pancreatic Cancer Undergoing Long-term Surveillance.
Marcia Irene Canto, Jose Alejandro Almario, Richard D Schulick...
https://pubmed.ncbi.nlm.nih.gov/29803839The Multicenter Cancer of Pancreas Screening Study: Impact on Stage and Survival.
Mohamad Dbouk, Bryson W Katona, Randall E Brand...
https://pubmed.ncbi.nlm.nih.gov/35704792